FDA revamps its Product-Specific Guidances for Generic Drug Development Web page to add new functionality, including text searching for active ingredi...
FDA clears a CoapTech 510(k) for the PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.
Edwards Lifesciences recalls its Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter due to difficulty in balloon de...
FDA clears a Biofourmis 510(k) for its RhythmAnalytics platform, a cloud-based software designed to automatically interpret cardiac arrhythmias.
Federal Register notice: FDA determines the regulatory review period for Cabaret Biotechs Yescarta (axicabtagene ciloleucel), indicated for treating a...
Public Citizen files a lawsuit in DC federal court against FDA over a 2016 citizen petition that the agency has not acted on that sought a boxed warni...
FDA Review posts the Federal Register notices for the week ending 4/26/2019.
FDA Review posts product approval summaries for the week ending 4/26/2019.